https://orcid.org/0000-0002-1288-024X
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Abstract
Aim
To identify whether COVID-19 vaccines should be administered in pregnant and breastfeeding women by reviewing the guidance and other evidence.
Methods
We reviewed the COVID-19 vaccination guidance for pregnant and breastfeeding women published to date and evidence from preclinical experimental and observational clinical studies, and discuss their implications.
Results
Pregnant women were excluded from the initial phase 3 clinical trials of COVID-19 vaccines resulting in limited data on their efficacy and safety during pregnancy and postpartum. As a result, since December 2020, there has been conflicting advice from public health, governmental, and professional authorities on this matter. From the end of 2020 up to now, some consensus guidance has been published with a prevalent precautionary approach on the administration of vaccines in pregnant women, in breastfeeding ones, or for those who are planning a pregnancy (either spontaneously or with assisted technologies). After the first few months of vaccine administration in some countries, more permissiveness seems to prevail, although with inconsistencies. At the moment, the results obtained by preclinical experimental and observational clinical studies suggest that the risks of the maternal COVID-19 outweigh the undocumented and hypothetical risks of the COVID-19 vaccines in pregnancy. Also, until two viral vector COVID-19 vaccines were associated with very rare thromboembolic events, all guidance had agreed that all approved COVID-19 vaccines could be administered in pregnancy. Actually, some concern has been expressed.
Conclusion
COVID-19 vaccines administered in pregnancy can reduce the risk of severe COVID-19 and their serious consequences for mothers and their offspring. However, many aspects remain to be clarified.
Disclosure statement
No potential conflict of interest was reported by the author(s).